Comparison of Translocator Protein Expression and Binding Activity in Normal Tissue Versus Non Melanotic Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01265472
Recruitment Status : Unknown
Verified December 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2010
Last Update Posted : December 23, 2010
Information provided by:
Rambam Health Care Campus

Brief Summary:
Translocator protein (TSPO) is a intracellular protein that is found primarily in the outer membrane of the mitochondria that is encoded by the TSPO gene. It has been found that TSPO expression in the skin correlates with cell proliferation and differentiation. Many studies have shown that TSPO overexpression in solid malignancies such as in ovarian cancer, colon cancer, and others, was also found to correlate with more aggressive cancer behavior. Working Hypothesis and Aims: Previous studies described an aberrant expression of TSPO levels in solid malignancies as compared to normal tissues. It is assumed that this aberration can be found in cuntaneous malignancies as well. The occurrence of this aberration may lead to the understanding of the mechanism of TSPO involment in the cutaneous malignancy, and in malignancies in general. Methods: The study will be carried out on surgically resected skin lesions suspected to SCC or BCC, which will be removed as part of the surgical routine treatment. The excision will be made in elliptic shape including the lesion and a part of normal skin surrounding it. A sample will be taken from the central part of the lesion and from the external extremity of the normal tissue. Western Blot will be conducted to detect the expression of TSPO. Binding activity with the TSPO specific ligandwill also be determined. Expected Results: We expect to observe either (a) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue or (b) a higher level of TSPO expression and a lower binding activity in malignant tissue compared with healthy control tissue. Importance: Until today, only a very small number of studies have examined TSPO in cutaneous malignancies, and these only examined TSPO expression. Our study will also measure the binding activity of TSPO in cutaneous malignant tissues compared to normal tissues

Condition or disease
Squamous Cell Carcinoma Basal Cell Carcinoma

Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Comparison of the Expression Level of Translocator Protein (TSPO) and Binding Activity in Normal Cutaneous Tissue Versus Non Melanotic Cutaneous Malignancy.
Study Start Date : January 2011
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : July 2011

Biospecimen Retention:   Samples Without DNA
Specimens of normal skin, squamous cell carcinoma or basal cell carcinoma

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Not an observational study.

Inclusion Criteria:

  • Clinical diagnosis of Basal Cell Carcinoma or Squamous Cell Carcinoma

Exclusion Criteria:

  • Non-compliance with inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01265472

Contact: Rafael Nagler, MD 972-4-854-3057

Sponsors and Collaborators
Rambam Health Care Campus

Responsible Party: Prof. Rafael Nagler, Rambam Health Care Campus Identifier: NCT01265472     History of Changes
Other Study ID Numbers: RMB455-CTIL
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: December 23, 2010
Last Verified: December 2010

Keywords provided by Rambam Health Care Campus:
Translocator Protein
Basal Cell Carcinoma
Squamous Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms, Basal Cell